Senior Clinical Research Associate

Danaher Corporation

. Set up, initiate, execute, monitor, and close out IVD and medical device clinical trials at external clinical research sites and/or laboratories .

Posted 10/5/2026full-timeRemote • United StatesSenior💰 $103,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trials, ensuring compliance with FDA standards and Good Clinical Practice, while effectively coordinating with external research sites and stakeholders. Proficient in clinical study protocol execution, data quality assurance, and regulatory documentation management.

Highest-signal resume keywords

Clinical Trial ManagementRegulatory ComplianceGood Clinical PracticeSite ManagementData Quality Assurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceProtocol ExecutionData CollectionIRB SubmissionsBudget NegotiationClinical Monitoring PlansAdverse Event AssessmentSample Procurement

Soft Skills

Relationship ManagementProject ManagementCommunication SkillsProblem-Solving

Tools & Technologies

Electronic Trial Master FilesClinical Trial Management Systems

Industry Keywords

In Vitro DiagnosticMedical DeviceCLSI StandardsFDA StandardsGood Clinical Practice

About the role

Key responsibilities & impact

Set up, initiate, execute, monitor, and close out IVD and medical device clinical trials at external clinical research sites and/or laboratories
Independently train and manage external clinical research sites
Oversee clinical study protocol execution from start-up to close-out, ensuring timely data collection and compliance with FDA standards and Good Clinical Practice
Develop and maintain relationships with institutions, study investigators, internal stakeholders, and vendors
Conduct independent study monitoring, including site coordination and investigational product accountability
Assess protocol deviations and/or adverse events and drive clinical data quality
Follow up on incomplete data entry and outstanding queries
Manage IRB submissions and study regulatory documentation
Keep the Trial Master File up to date and audit ready
Contribute to study planning, budget and contract negotiation, timeline forecasts, site identification and qualifications, and process improvement initiatives
Prepare study documents and create clinical templates, including informed consent forms and clinical monitoring plans

Requirements

What you’ll need

Bachelor’s degree with 5+ years clinical research experience OR Master’s degree with 3+ years clinical research experience OR Doctoral degree in field with clinical research experience
Basic knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products
Previous experience with managing clinical research sites and monitoring clinical study data
Good technical background to understand and communicate current and new technologies
Ability to work on multiple projects simultaneously
Ability to travel 20-70%, including overnight(s), within the US
Retrospective/prospective biological sample procurement experience preferred
Experience with electronic Trial Master Files and Clinical Trial Management Systems preferred
Demonstrated understanding of CLSI standards and their application to IVD clinical studies preferred

Benefits

Comp & perks

Health care program
Paid time off
Medical insurance
Dental insurance
Vision insurance
401(k)
Bonus/incentive pay
Flexible, remote working arrangements for eligible roles
Remote work from home